Tooth LossNCT02219139
A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps
A study testing ESTA abutment Roxolid in people with Tooth Loss, run by Institut Straumann AG at 1 site in Switzerland.
Trial summary
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- ESTA abutment Roxolid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have voluntary signed the informed consent form before any study related action.
- Males and females with at least 18 years of age
- Non-smokers
- Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype
- Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) <25% at abutment placement
- The patient must be able to open the mouth to allow removal of the abutment at the planned abutment site
Who cannot join
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any antibiotic treatment or anti-inflammatory treatment within the past 2 month
- Any contraindications for oral surgical procedures
- Mucosal diseases (e.g. lichen planus, mouth ulcer)
- History of local irradiation therapy
- Current treated (within the last 12 month) or untreated periodontitis
Show all 15Show fewer
- Current treated (within the last 6 month) or untreated gingivitis
- Probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental implant site
- Severe bruxing or clenching habits
- Lack of primary stability of the implant at abutment placement
- Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- Physical or mental handicaps that would interfere with the ability to follow protocol procedures
- Pregnant or breastfeeding wome
- Insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of the abutment platform or exposed ESTAnsurface) after abutment placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
Read the detailed description
One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration
- Conditions
- Tooth Loss
- Being tested
- ESTA abutment Roxolid
- Keywords
- Edentulous, Roxolid, SLAclive surface, Titanium/zirconium
- Medical subject headings
- Tooth Loss, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTA abutment RoxolidDevice
Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.
| Study group | Role | What they receive |
|---|---|---|
| ESTA abutment Roxolid | Other | One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration. Receives: Device: ESTA abutment Roxolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.
Measured: Inflammation assessment and biopsy at study day 70.
Secondary outcomes (6)
Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.
A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
Measured: 20-24 weeks
evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments
A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
Measured: 20-24 weeks
Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.
A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
Measured: 20-24 weeks
Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments
Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken
Measured: 9 weeks after abutment placement
Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments
8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then.
Measured: At 8 weeks after abutment placement
Evaluation of bacterial community at the abutment site
At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startDec 2012
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: No patients could be recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anton Sculean, Dr med dent, Principal investigator, University Bern, Zahnmedizinische Kliniken Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219139
- Sponsor's protocol ID
- CR 03/10 ESTA
- Other IDs
- CIV-12-10-009101
- Status last verified
- Mar 2016
- First submitted
- 17 Jul 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps
- ClinicalTrials.gov ID
- NCT02219139
- Acronym / sponsor ID
- CR 03/10 ESTA
- Conditions
- Tooth Loss
- Keywords
- Edentulous, Roxolid, SLAclive surface, Titanium/zirconium
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients could be recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
Detailed description
One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESTA abutment Roxolid | Other | Device: ESTA abutment RoxolidOne study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks. Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene. The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must have voluntary signed the informed consent form before any study related action.
- Males and females with at least 18 years of age
- Non-smokers
- Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype
- Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) <25% at abutment placement
Key exclusion criteria (15 listed)
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any antibiotic treatment or anti-inflammatory treatment within the past 2 month
- Any contraindications for oral surgical procedures
- Mucosal diseases (e.g. lichen planus, mouth ulcer)
- History of local irradiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESTA abutment RoxolidEnhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement. | Device | ESTA abutment Roxolid |
Primary outcome
Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
Time frame: Inflammation assessment and biopsy at study day 70.
A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.
6 secondary outcomes
Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.
Time frame: 20-24 weeks
evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments
Time frame: 20-24 weeks
Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.
Time frame: 20-24 weeks
Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments
Time frame: 9 weeks after abutment placement
Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments
Time frame: At 8 weeks after abutment placement
Evaluation of bacterial community at the abutment site
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Sculean, Dr med dent principal investigator
University Bern, Zahnmedizinische Kliniken Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTA abutment Roxolid in people with Tooth Loss, run by Institut Straumann AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments. (time frame: Inflammation assessment and biopsy at study day 70.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.